Analysis of wireless communication links between medical devices

ABSTRACT

A system and method of processing information regarding medical devices in wireless communication with each other is provided in which a controller device has a first wireless communication link with a first medical device, such as an analyte sensor, and a second wireless communication link with a second medical device, such as a delivery device. A processor in the controller device monitors the status of the first and second wireless links and upon noting a degradation of either one, compares the first wireless link status with the second wireless link status and provides guidance for resolving a communication problem based on the comparison. The latency of the communicating medical devices is considered.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/241,005, filed Sep. 9, 2009, incorporated by reference in itsentirety.

BACKGROUND

The present invention relates generally to wireless communications, andmore particularly, to monitoring the wireless link status of multiplewireless communication units to determine a reason for link degradation.

In some cases, medical device systems for disease management includesensor devices, medication delivery devices, processors, and/or controldevices that operate together to assist a patient in maintaininghealthier physiological processes. For example, in an integrateddiabetes mellitus management (IDM) system, a sensor is attached at oneposition on a patient's body for the purpose of sensing the patient'sglucose and providing a measurement signal representative thereof. Aninsulin pump is attached at a second position on a patient's body forthe purpose of delivering programmed amounts of insulin to the patientfor closely controlling the patient's glucose level. A third device, acontroller, is typically a hand-held device that is configured toreceive the glucose measurement signal, analyze it, and display arecommended dose of insulin to the patient. The patient may then controlthe insulin pump to deliver that recommended dose. In some cases, thedelivery pump is configured to provide data signals regarding past andongoing medication deliveries and the controller is also programmed toanalyze such pump delivery data signals in determining the recommendeddose of insulin provided to the patient.

Depending on the user, receipt and analysis of such sensor and pump datamay need to occur on a continuous basis to avoid user health problems.For example, a user with diabetes should continually receive such datato be able to take steps to avoid a hypoglycemic or hyperglycemiccondition, both of which can have serious consequences for the health ofthe user.

With the availability of low cost wireless technology, integratedsystems such as that discussed above become more convenient andacceptable in that wires are not needed to interconnect the devices. Notonly are wires burdensome to handle with on-body medical devices, butmany users desire to keep their medical affliction confidential, whichis more difficult to accomplish when wires exist. Each of the devices ofthe integrated system may incorporate a wireless communication modulethat allows it to communicate with at least one other device that uses awireless link. In some cases, the communication module of the device maybe a transceiver, but in other cases, it may simply be a receiver or atransmitter, depending on the function of the device.

Another important consideration with wireless radio frequency (RF)devices is their reliance on battery power. As is well known,transmitters typically tend to use far more battery power than receiversuse. Different types of transmitting protocols may be employed that useless power, such as burst transmission, or periodic transmission, asopposed to continuous transmission. Nevertheless, battery power is stillrequired and overuse of battery power can cause the premature expirationof the battery with the resulting requirement that the battery in thesubsystem be replaced, or the entire device replaced. In an IDM systemsuch as that discussed above, premature replacement of either thebattery or the device itself is highly undesirable due to the necessaryskin punctures that are required.

Referring now to FIG. 1, an IDM system 48 is shown. A glucose sensor 54provides glucose signals while the pump 64 provides medication deliverydata and pump status (such as programming) signals. Should both deviceswirelessly transmit their data simultaneously, interference may resultand the data may be lost since a receiver 70 may not reliably be able todiscern between the two. One method of avoiding interference between thetwo is to use two different frequencies. In the embodiment shown in FIG.1, the sensor-to-controller wireless RF link 50 would be a firstsubsystem 52 operating on a first frequency f₁ while thepump-to-controller wireless RF link 60 would be a second subsystem 62operating on a second frequency f₂, that is different from the firstfrequency.

An example of a medical system using multiple frequencies in itssubsystems is the integrated diabetes management (IDM) system beingdiscussed and shown in FIG. 1. In one embodiment, the glucose sensordevice 54 operates on 433 MHz, which is f₁. The insulin delivery pump 64operates on 2.4 GHz, which is f₂. Due to the large difference betweenthese two subsystem frequencies, interference is unlikely and betterdata communication is achieved. However, poor radio performance cannevertheless occur.

In the past, a radio subsystem that detects the existence of a degradedwireless link would increase the transmitting power to try to establishand maintain communications. However, this will have the effect offaster depletion of the battery as discussed above and may make thepremature replacement of a device undesirably necessary. Maintaining alower use of battery power to prolong the battery life of the devices ishighly desired.

In prior systems, if the radio performance was degraded below ausability threshold, the user was informed and given general guidance toresolve the problem. Such general guidance may have taken the form ofasking the user to determine general conditions of a device, such aschecking that a switch is in the “on” position, or to check thebatteries for viability, both of which are things that most users wouldhave already considered. Other, more specific guidance was not provided,and present systems are unable to provide helpful information orguidance specifically regarding resolution of wireless communicationissues when radio performance is degraded. Existing controllers, forexample, typically instruct transmitter modules to switch to acontinuous transmission mode in an attempt to establish a usablewireless link, or to increase the power level of transmission, both ofwhich are undesirable if they are not absolutely needed. Other systemssimply advise a user that a communication problem exists and that manualglucose testing, calculation, and pump analysis should be performed. Theabove techniques can result in considerable user inconvenience andanxiety, especially if the reason for the communication link degradationis easily correctable.

Hence, those skilled in the art have recognized the need for a systemthat is able to provide better guidance for correcting wirelesscommunication problems without invoking the excessive use of batterypower. A need has also been recognized for devices and systems that canprovide improved diagnosis of wireless communication link problems andthat can provide guidance that is more specific to users regardingcorrection of wireless communication problems between medical devices.The invention fulfills these needs and others.

SUMMARY OF THE INVENTION

Briefly and in general terms, the invention is directed to monitoringthe status of communication links among multiple medical devices andcomparing the status of those links to provide guidance to resolvecommunication link problems. The invention provides a system ofprocessing information regarding medical devices in wirelesscommunication with each other, the system comprising a base devicehaving a first wireless communication link with a first medical deviceand a second wireless communication link with a second medical device,and the base device having a processor configured to monitor the statusof the first wireless link and the status of the second wireless link,wherein the base device processor is further configured to determine ifa problem exists with one or more of the first and second links, andwherein the base processor is further configured to compare the firstwireless link status with the second wireless link status in the eventthat a problem with one or more of the monitored links is detected, andto provide guidance for resolving the problem based on the comparison.

In more detailed aspects, the processor is further configured to displaythe guidance on a visual display. The processor is further configured todetermine that a link problem does not exist if the monitored linkstatus lies within a latency of the respective medical device. Theprocessor is further configured to cause a system change to occur basedon the comparison. The processor is further configured to control thebase device to cease monitoring a link based on the comparison, wherebypower of the base unit is conserved.

In other detailed aspects, the processor is further configured to make adetermination of link status based on a selected time period and on atleast one characteristic of the respective medical device. The processoris further configured to issue an alarm based on the comparison and theselected time period. The processor is further configured to extend thetime period based on the comparison, before an alarm is provided. Theprocessor is further configured to determine the status of at least oneof the medical devices based on the link comparison. Additionally, theprocessor is further configured to monitor the communication links toidentify the existence of an intermittent communication link, and toconsider the intermittent link in the comparison.

In yet other aspects, each of the medical devices are battery poweredand the base station comprises a handheld battery-powered device, andthe processor is further configured to initiate a system status changebased at least in part on conserving battery power.

In accordance with the invention, there is provided a method ofprocessing information regarding a base station having a first wirelesscommunication link with a first medical device and having a secondwireless communication link with a second medical device, the methodcomprising monitoring each communication link, detecting a problem in atleast one of the communication links being monitored, determining if aproblem exists with one or more of the monitored communication links,comparing the status of the monitored communication links with eachother in the event that a problem appears to exist with one of thecommunication links, and providing guidance based on the link comparisonfor resolving the problem.

In more detailed aspects, the method further comprising displaying theguidance on a visual display. The method further comprising determiningthat a link problem does not exist if the monitored link status lieswithin a latency of the respective medical device. The method furthercomprising changing the system status based on the comparison. Themethod further comprising controlling the base device to ceasemonitoring a link based on the comparison, whereby power of the baseunit is conserved.

In other more detailed aspects, the method further comprising making adetermination of link status based on a selected time period and on atleast one characteristic of the respective medical device. The methodfurther comprising issuing an alarm based on the comparison and theselected time period. The method further comprising extending the timeperiod based on the comparison, before an alarm is provided. The methodfurther comprising determining the status of at least one of the medicaldevices based on the link comparison. The method further comprisingmonitoring the communication links to identify the existence of anintermittent communication link, and considering the intermittent linkin the comparison.

Further features and/or variations of the invention may be provided inaddition to those set forth herein. For example, the present inventionmay be directed to various combinations and subcombinations of thedisclosed features and/or combinations and subcombinations of severalfurther features disclosed below in the detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which constitute a part of thisspecification, illustrate various embodiments and aspects of the presentinvention and, together with the description, explain the principles ofthe invention. In the drawings:

FIG. 1 is a diagram of a user having an integrated diabetes managementsystem such as that described above, in which a pump and a glucosesensor are attached to separate body locations while a hand-heldcontroller is used to receive data from both and provide the user withrelevant information and recommendations for diabetes management, aswell as alarms;

FIG. 2 is a diagram showing a sleeping user with an integrated diabetesmanagement system monitoring glucose levels and transmitting pump statusdata, with the controller placed on a bedside table removed from thepatient;

FIG. 3 is a block diagram of an exemplary dual-transceiver systemconsistent with certain aspects related to the innovations herein, inwhich one transceiver is used to produce the wireless link of the sensorand a second transceiver is used to produce the wireless link of theinfusion delivery device;

FIG. 4 is a block diagram of an exemplary first (analyte monitoring)unit consistent with certain aspects related to the innovations herein,that includes various components, two of which are a communicationsection and a transceiver;

FIG. 5 is a block diagram of an exemplary base unit or hand heldcontroller consistent with certain aspects related to the innovationsherein, having first and second transceivers so that the status of bothRF links can be monitored and analyzed, and a processor for running alink status, comparison, and user guidance program;

FIG. 6 is a flow diagram illustrating an exemplary method of wirelesscommunication link monitoring and analysis showing Link 1, Link 2, andLink n (multiple links), as well as providing guidance to the user toresolve communication degradation problems; and

FIG. 7 is a chart illustrating how the status of multiple links can becombined to infer guidance for correcting communication problems,consistent with aspects of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As described in further detail below, in accordance with embodiments ofthe present invention, there is provided a system and method forfacilitating data processing and control for use in a medical telemetrysystem, and in particular for analyzing wireless communicationdegradation. In particular, the status of multiple wireless links arecompared to determine the cause for signal degradation and for providingthe user with guidance for correcting communication problems. A systemand method of facilitating data communication and/or control aspects foruse in medical telemetry systems such as, for example, in continuousglucose monitoring subsystems, medication delivery subsystems, andothers are described. The embodiments set forth in the followingdescription and in the drawings do not represent all embodimentsconsistent with the claimed invention. Instead, they are merely examplesconsistent with certain aspects related to the invention. Whereverpossible, like reference numerals will be used throughout the drawingsto refer to the same or to like elements.

Referring again briefly to FIG. 1, an integrated diabetes managementsystem 48 is shown that includes a glucose sensor 54 mounted to a user'supper arm 56. The glucose sensor may take the form of a continuousglucose sensor that punctures the user's skin and wirelessly transmitsdata representative of the sensed glucose level of the user.Transmission may occur every few milliseconds or may only occur onlyonce per minute depending on the glucose sensor used. A sensor of thistype is available from Abbott Diabetes Care Inc., Alameda, Calif., underthe name of the Freestyle Navigator® sensor.

An insulin delivery pump 64 forms part of the IDM system 48 and is alsowireless. In FIG. 1, it is mounted to a user's waist band and has tubing66 leading to an injection site 68. The injection site includes acannula that punctures the user's skin to deliver a medication, such asinsulin. However, other configurations are possible. In anotherconfiguration, the insulin pump 64 has a self-contained injectioncannula and the entire pump is mounted to a user's injection site byadhesive. The injection cannula is extended to puncture the user's skinfor the delivery of insulin. Control over the extension of the cannulato puncture the user's skin may be exercised by wireless command fromthe hand held controller 70, in such an embodiment.

The wireless communication link 60 may be used to receive insulindelivery status and other data from the pump 64, and may be used tocontrol the pump, such as by triggering insertion of the deliverycannula as described above. A representative insulin delivery pump ofthis type is the OmniPod® Pod pump from the Insulet Corporation, inBedford, Mass.

The remote controller 70 communicates with both the sensor 54 and withthe pump 64. To do so, the remote controller includes two transceiversin this embodiment. In one embodiment, the controller 70 receives thesensor data but also can query the sensor 54 for further data, therebyacting as a transceiver. In an embodiment, the controller 70 not onlyreceives pump data from the pump 64, but also can query the pump orprovide commands to the pump, as discussed above. The controller 70 alsotherefore has a transceiver for communicating with the pump. Pump datamay include the quantity of insulin already delivered as well as a timeframe reference so that the controller 70 can determine“insulin-on-board.” Pump data may also include the quantity of insulinalready programmed for future delivery as well as the time frame. Thecontroller analyzes this information in formulating a recommendation tothe user to increase insulin delivery, decrease insulin delivery, orcontinue with the insulin delivery as programmed.

To avoid interference in RF communications as discussed in theBackground section above, the wireless sensor 54 transmits and receivesat an RF frequency of 433 MHz while the delivery pump 64 transmits andreceives at an RF frequency of 2.4 GHz in this embodiment. Frequenciesdiffering greatly from those may be used in another embodiment. Becausethe remote controller 70 interfaces with both the sensor 54 and the pump64, it includes two transceiver modules, one of which operates on one ofthe above frequencies and the other of which operates on the otherfrequency. These are referred to herein as the sensor subsystem 52 andthe pump subsystem 62. This is not meant to be restrictive in that othertypes of subsystems or overall systems having different operationalfrequencies apply as well. Each of these radio subsystems operatesindependently and each of the radio frequencies or bands has uniquecharacteristics. For example, the operating range, types of interferers,propagation characteristics, and latency of each subsystem is differentin this embodiment. The differences between each radio subsystem'sperformance characteristics and the combined resulting behaviors can beused to characterize the operating environment.

For each radio subsystem 52 and 62, there are conditions that prevent ordegrade their communications link 50 and 60 respectively, such asdistance, antenna orientation, intervening objects, and co-channelinterference. When the respective devices 54 and 64 cannot communicatewith the remote controller 70, the remote controller, without moreinformation, cannot determine the exact cause. By combining informationabout the performance of two (or more) radio links, the controller canpossibly determine the cause and the user can be given more specificguidance on how to resolve the problem that is causing communicationlink degradation.

Referring to FIG. 2, the user is sleeping with the controller 70 placedat a distance on a nightstand 72. The controller is programmed to issueaudible, vibratory, and visual alarms when certain glucose conditions ofthe user occur in this embodiment. Also in this embodiment, the IDMsystem 48 is using a continuous sensor 54 and a programmed delivery pump64. The controller 70 expects to wirelessly receive data from bothdevices regularly so that the user's glucose condition may be monitored.Should the wireless data flow from one or more of the sensor device orthe delivery pump be interrupted due to a degradation in a communicationlink or links, the controller 70 may sound an audible and/or vibratoryalarm to awaken the patient. In accordance with aspects of theinvention, the controller will also provide information to the patientregarding the faulty communication link. The patient may then take stepsto remedy the problem.

In accordance with aspects of the invention, the status of both RF linksof the two radio subsystems 52 and 62 (FIG. 1) can be compared in aneffort to reach some conclusion about the cause of degraded or noperformance. Perhaps in the simplest case, a communication link analysisprogram run by the controller 70 would review the signal strength ofeach device's wireless link 50 and 60 to the controller. In finding thatboth links are nonexistent, the controller could determine that theremote controller is out of range of the user, the remote controller isoff, or the battery is depleted. Such an occurrence could arise if theuser left the remote controller in another part of the house beforeretiring. The controller would issue a loud audible alarm to attract theuser's attention. The user may then retrieve the controller and place itwithin range of the medical devices 54 and 64.

In the one embodiment, the RF subsystem 62 (FIG. 1) between the pump 64and the controller 70 would be operating at 2.4 GHz. While thetransmission range at this frequency can be around 100 meters (severalhundred feet), the need to conserve battery power dictates that thetransmission range be limited to approximately one to two meters (threeto seven feet). This frequency in the medical field is considered tohave a “shorter” range. The RF subsystem 52 between the sensor 54 andthe controller would be operating at 433 MHz. This frequency has atransmission range (at reduced power to conserve battery power) ofapproximately 30.5 meters (100 feet), which is considered to be a“longer” range. It has also been observed that both frequencies aresusceptible to interference from various objects. At 2.4 GHz, the humanbody can provide significant interference. In FIG. 2, the pump 64, whichoperates wirelessly at 2.4 GHz, is located on the far side of the userfrom the controller 70. The user's body could provide significantinterference to the communication link 60 if he were to roll to hisright. However, the user's body would not significantly interfere withthe operating frequency of the sensor 54 at 433 MHz. One reason is thatthe user's body is not disposed between the sensor and the controller70, and another reason is that the user's body does not providesignificant interference at that frequency.

Another characteristic of the two different frequencies of operation isthat the 433 MHz subsystem has a lesser signal latency than the 2.4 GHzsubsystem. The term “latency” or “signal latency” as used herein isgenerally meant to mean the time between transmissions of a device. Thusif a glucose sensor 54 transmits only once per minute, it has a latencyof a minute. Transmission at such a low rate is possible due to the needto conserve battery power so that the sensor can remain on the user'sarm for a full three days.

Another example in which the controller 70 having a multiple radio-linkanalysis program running is when the longer-range subsystem 52 is ableto communicate but the shorter range subsystem 62 is not. The programcould then determine that the distance between the user and the remotecontroller 70 is likely somewhere between the two ranges of the RFlinks. A further example is the case where the longer latency subsystemcannot communicate, and the lower latency subsystem communication hasbeen intermittent. The program would determine that the user is likelymoving in and out of range of the medial devices with the remote control70. Therefore by combining information about the performance or statusof two or more radio links, the controller may be able to provide moreuseful information and guidance to the user to make adjustments so thatthe communication links are established and maintained in good workingorder.

FIG. 3 illustrates a data processing, monitoring and management systemsuch as, for example, an integrated diabetes management (IDM) system 100consistent with certain aspects of the invention. The subjectinnovations are further described primarily with respect to an analyte(e.g., glucose) monitoring and management system for convenience andsuch description is in no way intended to limit the scope of theinvention. It is to be understood that the innovations herein areapplicable to configurations related to the processing of data and themanagement of a variety of medical devices, and the monitoring of avariety of analytes, e.g., lactate, and the like.

Analytes that may be monitored include, for example, acetyl choline,amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase(e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growthhormones, hormones, ketones, lactate, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be monitored.

Continuing to refer to FIG. 3, an exemplary data processing, monitoring,and management system 100 comprises a sensor 101, a firstprocessing/transceiver unit 102 coupled to the sensor 101, a baseprocessing unit 110, and a second processing/transceiver unit 105. Thebase unit 110 is configured to wirelessly communicate with the firstprocessing/transceiver unit 102 via a first transceiver subsystem 112over a first RF link 113, and with the second processing/transceiverunit 105 via a second transceiver subsystem 114 over a second RF link115. The base unit 110 may be, for example, a portable or handheldcomputing component that serves as a remote management/control devicesuch as the hand held controller 70 of FIGS. 1 and 2, and may includeone or more subcomponents 116 for processing wireless communicationdata, and storing data or software such as applications enabling theinnovations herein, among other things. For example, the base unit 110may consist of, or include, a personal computer, a portable computingcomponent such as a laptop or a handheld device (e.g., personal digitalassistant (PDA), smart phone, etc.), and the like. Additionally, thebase unit 110 and the other units 102 and 105 may further be connectedto a data network 120 for storing, retrieving and updating data orprograms, such as those associated with the innovations herein. Thisdata network may comprise an internal facility network such as a localarea network or a wide area network, the Internet, or other network.While various processing features throughout this disclosure may beillustrated as occurring in one particular unit, it should be understoodthat the functionality may be distributed among one or more of theprocessors within any suitable unit in the system 100.

According to certain implementations, the first and secondprocessing/transceiver units 102 and 105 may be on-body devicesassociated with a glucose monitoring and insuling pumping devices usedfor management of a medical condition. In some illustrative systems, thefirst processing/transceiver unit 102 may be a component of a continuousglucose monitoring (“CGM”) subsystem that is linked to the base unit 110via the first wireless communications link 113, and the secondprocessing/transceiver unit 105 may be a processing component of aninsulin delivery pump subsystem that is linked to the base unit viasecond wireless communications link 115. In one embodiment, the sensor101 may comprise the Freestyle Navigator® sensor and the firsttransceiver unit 102 may be integrated with that sensor, or may be aseparate transceiver unit that electrically connects and mechanicallycouples to the sensor. The infusion device 109A may take the form of aninsulin pump and the second transceiver 105 may be integrated within thehousing of the pump as shown in box 105, or may have a separate housing109B that electrically connects and mechanically couples to the pump asshown in dashed lines. Other configurations are possible.

In one illustrative embodiment, the IDM system 100 may include a CGMsubsystem 102 that wirelessly communicates using 433 MHz signals, or 2.4GHz or 315-322 MHz signals, or other, and the pump subsystem 105 thatuses a different frequency, such as 2.4 GHz or 433 MHz, or other,signals. In general, methods and systems consistent with the innovationsherein first determine information regarding a first status of the firstwireless link 113 and a second status of the second wireless link 115,wherein various problems/issues associated with wireless communicationsor the links may also be identified. Then, based on the informationdetermined, intelligence is provided to a user. This intelligence mayinclude information regarding one or more of the devices (e.g.,location, status, etc.) and/or diagnosis, guidance, or resolutionregarding any of the problems/issues identified, among other things.

By way of one example, in the illustrative 433 Mhz/2.4 GHz subsystemsmentioned above, exemplary methods and systems may first determine atransmission state or link status or condition for each subsystem.Various transmission states and link status or conditions are set forththroughout this disclosure and may include whether the link is operatingnormally, whether the link is operating intermittently, whether the linkis nonexistent, the status of short range transmissions, and the statusof long range transmissions, among other things. Once informationregarding the status of each link is determined, methods and systemsherein may process this information using logic keyed to the particulardevices and transmission protocols involved, and then provide the userwith feedback regarding one or more of the devices (e.g., location,status, etc.) and/or diagnosis and guidance for resolution of anyproblems/issues identified, among other things. Various examples ofdevice-related feedback are set forth throughout this disclosure and mayinclude whether or not a device is in range of a transceiver, whether adevice in intermittently moving into/out of range, whether or not a useris within or outside of one or more specified ranges, etc.

In determining the status of a link, the system 100 also considers thelatency characteristic of each subsystem. For example, when a device isprogrammed to transmit only once per minute, the device is notnecessarily “intermittent” is no transmission has been received forforty-five seconds. The device's latency is considered in making adetermination of whether or not transmissions from the device are beingreceived “intermittently.”

Hardware and/or software applications may be employed to enable thelogic, keyed to the particular devices and transmission protocols, usedby the method and system herein. For example, this logic may beimplemented via a database as well as associated program code thatallows access and utilization of data within the database. Suchfunctionality may be installed in one or more of the devices or units,or it may be provided via wired or wireless connection, computerreadable media download, or other suitable means. Such logic or databasemay include information regarding an interferer (e.g., objects that mayinterfere with communications, sources or causes of interference), apropagation characteristic (e.g., performance, signal data, frequency,signal strength), or a latency (e.g., temporal, and related aspects) ofthe communications between the units, and this information may be usedin determining feedback for the user, such as device status or devicelocation information, diagnosis of, guidance regarding, or a resolutionof a wireless-communication-related problem. Various diagnoses,guidance, or resolution of identified issues/problems are set forththroughout this disclosure or inherently flow from the issue/problemsidentified and may include an “out of range” notification, a vicinitydetermination, a message regarding a device location or request to movea device, a message regarding verification of a transmission or devicedetail, a recommendation regarding adjusting a transmission or devicedetail, a message to check for and/or avoid one or more likely causes ofinterference, and a recommendation regarding a transmission or channelselection, among others.

In the exemplary implementation of FIG. 3, the first and secondtransceiver units 112 and 114 of the base unit 110 are shown as beingwirelessly linked to their respective first and second units 102 and 105for wireless data transmission. While shown as being separate anddistinct in FIG. 3, the first transceiver unit 112 and the secondtransceiver unit 114 may, more generally, be embodied within a moreunitary transceiving section 111 that utilizes or shares components orfunctionality between transceivers as appropriate. Moreover, while notshown, the first transceiver 112 may also be configured to communicatewith the second unit 105, and the second transceiver 114 may also beconfigured to communication with the first unit 102. In anotherarrangement, each unit of the system may be configured forbi-directional wireless communication with any of the other units.

Only one sensor 101, first unit 102, base unit 110, and second unit 105are shown in the exemplary implementation of the diseasemanagement/monitoring system 100 illustrated in FIG. 3. However, it willbe appreciated by one of ordinary skill in the art that the system 100may include one or more sensors 101, first units 102, base units 110,and second units 105. Moreover, within the scope of the presentdisclosure, the system 100 may include a continuous analyte monitoringsystem, or semi-continuous, or a discrete monitoring system. Further, insuch multi-component environments, each device may be configured to beuniquely identified by each of the other devices in the system so thatcommunication conflict is readily resolved between the variouscomponents within the system 100.

In one implementation of the present disclosure, the sensor 101 isphysically positioned in or on the body of a user whose analyte level isbeing monitored. The sensor 101 is configured in one embodiment tocontinuously sample the analyte level of the user and convert thesampled analyte level into a corresponding data signal for transmissionby the first unit 102 on a periodic basis. In one implementation, thefirst unit 102 is coupled to the sensor 101 so that both devices arepositioned on the user's body, with at least a portion of the analytesensor 101 positioned transcutaneously under the skin layer of the user.The first unit 102 may perform data processing such as filtering andencoding on data signals, each of which corresponds to a sampled analytelevel of the user, for transmission to the base unit 110.

In one exemplary implementation, the system 100 may be configured as aone-way RF communication path from the first unit 102 to the base unit110. In such implementation, the first unit 102 transmits the sampleddata signals received from the sensor 101 without acknowledgement fromthe base unit 110 that the transmitted sampled data signals have beenreceived. For example, the first unit 102 may be configured to transmitthe encoded sampled data signals at a fixed rate (e.g., at one minuteintervals) after the completion of the initial power-on procedure.Alternatively, the system 100 may be configured with a bi-directional RF(or otherwise) communication between the first unit 102 and the baseunit 110.

The base unit 110 may include a data processing section 116 that isconfigured to process data such as that received from the first andsecond units 102 and 105 respectively. It may additionally processinstructions regarding the other units. Additionally, in one aspect, anexemplary base unit 110 may also include an analog interface sectionthat is configured to communicate with the first unit 102. In oneimplementation, the analog interface section may include an RF receiverand an antenna for receiving and amplifying the data signals from thefirst unit 102, which, thereafter, may be demodulated with a localoscillator and filtered through a band-pass filter.

In operation, the base unit 110 may be configured to detect the presenceof the first unit 102 or the second unit 105 within its range as afunction of, for example, the signal strength of the detected datasignals received or from predetermined transmitter identificationinformation. Upon successful synchronization with a corresponding unit102 or 105, the base unit 110 may be configured to begin data receiptand processing, such as to begin receiving from the first unit 102 datasignals corresponding to the user's detected analyte level, to transmitand receive data with the second unit 105 regarding infusion-relatedcommunications 109. For example, the base unit 110 in one implementationmay be configured to perform synchronized time hopping with thecorresponding synchronized first and/or second units via the respectivecommunication links.

Within the scope of the present disclosure, as shown in FIG. 3, thesecond unit 105 may be coupled to an infusion device 109B, such as aninsulin infusion pump or the like, which may be configured to administerinsulin to patients, and which may be configured for communications withthe base unit 110 to receive, among other things, data or instructions.The insulin delivery pump 105 may also be configured to forward data tothe base unit 110 representative of insulin already delivered over aparticular time frame and the remaining insulin to be delivered inaccordance with current programming instructions. From this,insulin-on-board can be calculated by the base unit, and the effects ofinsulin to be delivered can be predicted. As a result, changes ininsulin delivery may be calculated at the base unit 110. Alternatively,the second unit 105 may be configured to integrate an infusion device109A therein so that the second unit 105 is configured to administerinsulin therapy to patients, for example, for administering andmodifying basal profiles, as well as for determining appropriate bolusesfor administration based on, among others, the detected analyte levelsreceived from the first unit 102. Such medical techniques, i.e.,boluses, basal rates, can also be employed by the separate device 109B.

The first unit 102, the base unit 110, and the second unit 105 may eachbe configured for bi-directional wireless communication such that eachof the first unit 102, the base unit 110 and the second unit 105 may beconfigured to communicate (that is, transmit data to and receive datafrom) with each other via one or more wireless communication links inanother embodiment. Further, the second unit 105 may in oneimplementation be configured to receive data directly from the firstunit 102 via a communication link (not shown), which may be configuredfor bi-directional communication.

In some implementations, the first unit 102, base unit 110, and secondunit 105 may be configured to wirelessly communicate via communicationlinks including one or more of an RF communication protocol, an infraredcommunication protocol, a Bluetooth enabled communication protocol, an802.11x wireless communication protocol, a Zigbee transmission protocol,or an equivalent wireless communication protocol which would allowsecure, wireless communication of several units (for example, per HIPPArequirements) while avoiding potential data collision and interference.All of these are referred to as “wireless” herein.

FIG. 4 is a block diagram of an exemplary first unit 102 shown in FIG. 3in accordance with one embodiment. The first unit 102 in oneimplementation may include an interface 201 configured to communicatewith the sensor 101 (FIG. 1, W, G, R, and C being electrodes), a userinput 202, and a temperature detection/measurement section 203, each ofwhich is operatively coupled to a processor 204 such as a centralprocessing unit (CPU). The user input may take many forms, such as atouch screen, keypad, keyboard, and others. Further shown in FIG. 4 area communication section 205 and a wireless transceiver 206, each ofwhich are also operatively coupled to the processor 204. Moreover, apower supply 207, such as a battery, is also provided in the first unit102 to provide the necessary power for the first unit. Additionally, ascan be seen from the FIG. 4, a clock 208 is provided to, among otherthings, supply real time information to the transmitter processor 204.

In one implementation, an input path is established from the sensor 101(FIG. 1) and/or other suitable test or data component to the analoginterface 201 of the first unit 102, while an output is established fromthe output of the transceiver 206 of the first unit 102 for transmissionto the base unit 110. As such, via this path the first unit 102 isconfigured to transmit to the base unit 110 processed and/or encodeddata signals received from the sensor 101 (FIG. 1).

As discussed above, the first unit processor 204 may be configured totransmit control signals to the various sections of the first unit 102during the operation of the first unit. In one implementation, theprocessor 204 also includes a memory 210 for storing data such as theidentification information for the first unit 102, as well as the datasignals received from the sensor 101. The stored information may beretrieved from the memory and processed for transmission to the baseunit 110 under the control of the processor 204. Furthermore, the powersupply 207 may include a commercially available battery.

The first unit 102 is also configured such that power supplied from thepower supply section 207 may be controlled via feedback received fromthe base unit 110. Specifically, the base unit 110 may transmitinstructions for controlling the provision of power and the operation ofthe transceiver 206, to improve power management. For example, when theuser is out of range of two wireless communications links, the base unitcan save energy by using just one link instead of two to determine whenthey are back in range. The power supply may be reduced to a very low“sleep” mode output in such case, through instructions from the baseunit 110 to the processor 204.

Typically, the power supply 207 is capable of providing power to thetransmitter 206 for a minimum of about three months of continuousoperation after having been stored for about eighteen months in alow-power or non-operating mode. In one implementation, this may beachieved by the processor 204 operating in low power modes in thenon-operating state, for example, drawing no more than approximately 1μA of current. Moreover, as shown in FIG. 4, while the power supply unit207 is shown as connected with to the processor 204, and as such, theprocessor 204 is configured to provide control of the power supply unit207, it should be noted that within the scope of the present disclosure,the power supply unit 207 may be also be directly connected to each ofthe other components 201, 214, 202, 203, 208, 205, 206, 210, and 215 inan embodiment to provide the necessary power to each of the componentsof the first unit 102 shown in FIG. 4. Additionally in anotherembodiment, the power supply 207 may have its own internal processor andprogramming to provide “smart” power control.

In some implementations, the power supply section 207 of the first unit102 may include a rechargeable battery unit that may be recharged by aseparate power supply recharging unit (for example, provided in the baseunit 110) so that the first unit 102 may be powered for a longer periodof usage time. Moreover, in one implementation, the first unit 102 maybe configured without a battery in the power supply section 207, inwhich case the first unit 102 may be configured to receive power from anexternal power supply source (for example, a battery) as discussed infurther detail below.

Referring further to FIG. 4, the temperature measurement section 203 ofthe first unit 102 maybe configured to monitor temperature(s) associatedwith the user, such as that of the skin near the sensor 101 (FIG. 3)insertion site. The temperature reading may be used by the processor toadjust the analyte readings obtained from the interface 201 or maysimply be stored for possible analysis later. The transceiver 206 of thefirst unit 102 may be configured for operation in the frequency band ofabout 433 MHz, or other frequencies, such as 315 MHz to 322 MHz, forexample. Further, in one implementation, the transceiver 206 isconfigured to modulate the carrier frequency by performing FrequencyShift Keying and Manchester encoding. In one implementation, the datatransmission rate is 19,200 symbols per second, with a minimumtransmission range for communication with the base unit 110.

Referring yet again to FIG. 4, also shown is a detection circuit 214coupled to one or more electrodes (W, G, R, or C) of the sensor 101(FIG. 3) and the processor 204 in the first unit 102. The detectioncircuit 214 in accordance with one implementation of the presentdisclosure may be configured to detect leakage current in the sensor 101to determine whether the measured sensor data are corrupt or whether themeasured data from the sensor 101 is accurate.

Additional data monitoring systems and devices consistent with theinnovations herein are provided in U.S. Pat. No. 6,175,752 issued Jan.16, 2001 entitled “Analyte Monitoring Device and Methods of Use”, and inapplication Ser. No. 10/745,878 filed Dec. 26, 2003, publication No.US2004/0186365A1, entitled “Continuous Glucose Monitoring System andMethods of Use,” each assigned to the Assignee of the presentapplication, and each of which are incorporated herein by reference inentirety for all purposes.

FIG. 5 is a block diagram of an exemplary base unit 110 of the system100 shown in FIG. 3 consistent with aspects related to the innovationsherein. Referring to FIG. 5, the base unit 110 may optionally include ablood glucose test strip interface or reader 301, a wireless firsttransceiver 112, a user input 303, a temperature monitoring section 304,and a clock 305, each of which is operatively coupled to the processorand memory component 116 (also referred to as just “processor”). As canbe further seen from FIG. 5, the base unit 110 also includes a powersupply 306 operatively coupled to a power conversion and monitoringsection 308. Further, the power conversion and monitoring section 308may also be coupled to the processor 116. Moreover, also shown are asecond transceiver 114, and an output display 310, such as a visualdisplay, audible signal generator, vibratory signal generator, andpossibly others, which may each also be operatively coupled to theprocessor 116.

In one implementation, the test strip interface 301 may include aglucose level testing reader to receive a manual insertion of a glucosetest strip, for determination, transmission, and/or display of thedetected glucose level shown by the test strip on the output 310 of thebase unit 110. This manual testing of glucose can be used to calibrateanalyte sensing components, such as the sensor 101 (FIG. 3). The firstwireless transceiver 112 may be configured to communicate with thetransceiver 206 of the first unit 102, to receive encoded data signalsfrom the first unit 102 for, inter alia, signal mixing, demodulation,and other data processing. The user input 303 of the base unit 110 isconfigured to allow the user to enter information into the base unit 110as needed. In one aspect, the input 303 may include one or more keys ofa keypad, a touch-sensitive screen, a voice-activated input commandunit, or other means. The temperature measurement section 304 isconfigured to provide temperature information of the base unit 110 tothe processor 116, while the clock 305 provides real time information tothe processor 116.

Each of the various components of the base unit 110 shown in FIG. 5 ispowered by the power supply 306 which, in one implementation, includes abattery. Further, the logic described herein may control provision ofpower and operation of the base unit 110, i.e., as a function of theinnovations herein regarding communication link information, to improvepower management. For example, the processor may execute or run programsto reduce the transmit power level, reduce the retry rate, idle all butone RF link, and rely on that one link to determine the link status.Additionally, the power conversion and monitoring section 308 may beconfigured to monitor the power usage by the various components in thebase unit 110 for effective power management and to alert the user, forexample, in the event of power usage that renders the base unit 110 insub-optimal operating conditions. An example of such sub-optimaloperating condition may include, for example, operating the transceiverat a full power level when the unit to which or from whichcommunications are being sent or received is out of range, or using avibration output mode for an excessive period of time thus substantiallydraining the power supply 306. Moreover, the power conversion andmonitoring section 308 may additionally be configured to include areverse polarity protection circuit such as a field effect transistor(FET) configured as a battery activated switch.

The second transceiver 114 in the base unit 110 may be configured toprovide a bi-directional communication path from the testing and/ormanufacturing equipment for, among others, initialization, testing, andconfiguration of the base unit 110. The communication section 309 canalso be used to upload data to a network or other computer, such astime-stamped blood glucose data stored in the memory 116, or in realtime. Such communication links may also be utilized to connect tonetworks, supervisory individuals or entities, healthcare providers, orthe link. Communication links with external devices (not shown) can bemade, for example, by cable, or wireless, such as by infrared (IR) or RFlink. The output 310 of the base unit 110 is configured to provide,among others, a graphical user interface (GUI) such as a liquid crystaldisplay (LCD) for displaying information. Additionally, the output 310may also include an integrated speaker for outputting audible signals aswell as to provide vibration output as commonly found in handheldelectronic devices, such as mobile telephones or “smart” phones. In afurther embodiment, the base unit 110 also includes anelectro-luminescent lamp configured to provide backlighting to theoutput 310 for output visual display in dark ambient surroundings.

Although an RF link analysis program may be stored in theprocessor/memory unit 116, it is shown separately here in box 312. Theprocessor 116 runs this program to determine the status of all RF linksand to analyze those links when a wireless communication problemdevelops. Based on the analysis made by the RF link program 312, theprocessor 116 provides guidance to the user by means of the output 310visually and/or audibly.

FIG. 6 is a flow diagram illustrating an embodiment of a portion of amethod in which the status of each of multiple wireless communicationlinks is analyzed and compared to the status of the other links toidentify a communication problem. Referring to FIG. 6, an exemplarymethod 350 comprises processing information regarding wireless linksassociated with two or more wireless communication subsystems 352, inthis case Link 1, Link 2, and Link n, determining link status associatedwith transmissions made or attempted by each of the subsystems 354, anddetermining if there are any changes to the status of each link 356.Changes to a link status includes the link becoming intermittent ornon-functional. Another status change includes a non-functional linkbecoming functional. Thus, boxes 354, as an example, make adetermination of link status as being normal, intermittent, none-shortduration, and none-long duration. Next the program determines whetherthere has been a change in a link status 356 from what was determined inboxes 354. If there has been a change, the method then moves to adetermination of system status 358.

Examples of system status are “normal,” “pump off body,” “moving in/outof range,” and “left behind.” The system status determination 358 isthen compared to the present system status an if a change is detected360, a link recovery state is determined 362. If the system statuschange has been a return to a “normal” status, the processor may displaya message to a user of “Normal status-all links active” or similarmessage. If however, a link has gone down and the system has moved to analarm status, the method may then put the handheld controller into apower conservation mode in which it ceases monitoring certain links, orsets a time period in which it stops monitoring a particular link, suchas ten minutes, but after that period has elapsed, the handheld mayagain check for the existence of the link. In the meanwhile, an alert isprovided to the user. Also, the method moves to and then poll the downlink again, such as a ten minute period.

Guidance is provided to the user 364 as a result of the steps discussedabove. Examples are “none,” “query to confirm pump inactive,” “movecontroller closer to work area,” “alarm,” and “power conservation mode.”If all links are operating normally and the system status is normal, theguidance to the user may take the form of “system normal” or othersimilar message, in one embodiment. However, if one link is down, theguidance may take the form of “keep the handheld on your person for thenext ten minutes” or similar message. Other guidance is possible, suchas check battery status in a device, or other.

Link status here may include various information regarding the wirelesslinks set forth throughout this disclosure or otherwise known to anordinary artisan, such as status or state of messages communicationattempts, information regarding the wireless connections or protocolsinvolved, etc., including whether the link is operating normally,whether the link is operating intermittently, status of short rangetransmissions, status of long range transmissions, bit error rate, andreceived signal strength, among other things.

Once status/information regarding the wireless links has been determined354, the step of determining whether a change has occurred 356 isperformed and includes utilizing or accessing logic (hardware, software,firmware, databases, etc.) that contains specific information regardingone or more of the wireless transmission protocols being used, theusers, the transceiver units or their devices, the environments in whichthey will or are likely to be used, and/or other technical or wirelesstransmission details regarding transmission or usage of the devices.Such logic may, for example, include information regarding aninterferer, a propagation characteristic, or a latency of thecommunications between the units. As used here, interferers may be, forexample, objects that interfere with communications, other sources orcauses of interference, co-channel users; and unintentional RF noisesources, etc. Propagation characteristics may be, for example,characteristics relating to signal performance, signal data, frequency,signal strength, receiver sensitivity, etc. And latency elementsinclude, for example, factors relating to temporal aspects, arrivaltimes, packet transmission rate, etc. In the case of a sensor 54 thathas a latency of one minute, a link status change will not be noteduntil more than one minute has elapsed between transactions with thesensor. Even then, the processor of the handheld 70 may be programmed topermit five minutes to elapse before an alarm is raised concerning theglucose sensor 54. That is, a “system change” or issuing an alarm willnot occur even though a “link status change” with the sensor hasoccurred, in this example. The same is possible for other occurrencesrelating to various system components.

Turning now also to FIG. 7, a chart some examples of system and linkstatus are given. The rows R1 through R4 indicate the link status of onewireless device 400 while the columns C1 through C4 indicate the linkstatus of another wireless device 410, both of which are communicatingwith a base station 110, which may take the form of the handheld device70 discussed above. In the examples given, the glucose sensor is assumedto be continually attached to the user's body. The pump can betemporarily detached from the user's body. The controller can be left inanother room or left at home. In the case of R1-C1, all is normal. Inthe case of R2-C1 where one device link status is “intermittent” whilethe link status of the other device is “normal,” the diagnosis of thesystem may be that the user is moving in and out of range, but there isno need for a system change at this time. That is, the system continuesto function without change. However the processor may cause an icon tobe displayed on the screen indicating that an intermittent link with aparticular device has been detected. Such a display is not considered tobe a system change since the system continues to operate as before.

In the case of R3-C1, the situation labeled as “(1)” is found. In thatcase, a short duration interruption in a link exists but no systemchange is warranted again, because the logic may determine that this ispossibly a normal case. Such a case often arises when the user is takinga shower and has placed the controller and pump together during thattime. However, if the link status remains “none” for a “long duration,”the chart moves to R4-C1, which is the situation labeled as “(2),” andan alarm is given. In this case, the link has been nonexistent for a“long” duration and action is recommended to the user.

Moving to the case of R4-C4, the situation of “(3)” is found. In thiscase where there has been no communication for a “long” duration, anaudio alarm is not given. To save battery energy, the handheld does nottry to link with the pump until the link with the sensor has beenrestored. The handheld thus makes a system change in that it monitorsonly one link now, i.e., the sensor link. Typically, once the userdetermines that he or she has left the controller behind, the user willretrieve the controller which will reestablish the sensor link. Thecontroller will then switch the monitor system for the pump back on andwill then reestablish that link.

Turning now to R1-C3 of FIG. 7, the situation labeled as “(4)” has beendetected but no alarm is given. For a pump, the wait from short durationto long duration of no link may vary depending on how much insulin is inthe pump and how long it takes to detect an occlusion, and if the basalrate changes (time of day). If the duration goes to R1-C4, which is a“long” duration, an alarm is given. In the case of R3-C3, which isindicated by “(5),” an alarm is not given. If nothing changes however,the state will either go to the cell to the right or the cellimmediately below, both of which require that an alarm be given.Transitioning to R3-C4 or to R4-C3 depends on the definition of “long”as programmed. Such may be determined by reference to situation (3)above.

In the above-described embodiments, the system is event driven.Communicating or failing to communicate on each link is the drivingevent. Each link has its own schedule so the events are asynchronous.Each time a link status changes 356 (FIG. 6), the next level of logiclooks to see if the change constitutes a system status change 358. Forexample, a link going from “normal” to “intermittent” is a Link StatusChange 356 but may not be a System Status Change 358. If the systemstatus changes 360, then two independent actions are possible. First,the link recovery state 362 may reconfigure a link device driver, forexample, to completely disable one link. Second, the Diagnostics andGuidance 364 may alert the user, change a displayed icon, etc., tointeract with the user. When a link status changes 356, the methodexecutes the system status block 358 which could involve a tablelook-up, a sequence of case statements, or some other step to implementthe logic.

Information, diagnoses, guidance and/or problem resolutions developedfrom these determinations may then, optionally, be provided to a user364. Further exemplary determinations, here, may also include developinghelpful feedback to users of the units, such as providing specific orindividualized device status or device location information, diagnosisof, guidance regarding, or a resolution of awireless-communication-related problem, and the like. Various examplesof diagnosis; guidance, or resolution of identified problems are setforth throughout this disclosure and may include an “out of range”notification, a “vicinity” determination, a message regarding a devicelocation or request to move a device, a message, regarding verificationof a transmission or device detail, a recommendation regarding adjustinga transmission or device detail, a message to check for and/or avoid oneor more likely causes of interference, a recommendation regarding atransmission or channel selection, among others.

Other exemplary logic and determination functionality may, with regardto units having Bluetooth enabled communications, include performing aBluetooth channel usage/availability scan, wherein the information forprovision to the user is determined based on results from the scan.According to these aspects, analysis of information derived from thescan is factored into the information determined for or provided to theuser. For example, if one or more channels are determined to be in use,the method may recommend a different channel or use of a differenttransmission protocol. Further, if as a result of the scan the presenceof a source of interference is identified, the method may againrecommend use of a different protocol or some other means by which theidentified interference can be avoided. Moreover, results from similarscans in wireless technologies other than Bluetooth may be used in alike fashion.

Referring back to FIG. 5, the base unit 110 in one implementation mayalso include a storage section such as a programmable, non-volatilememory device as part of the processor 116, or provided separately inthe base unit 110, operatively coupled to the processor 116. Theprocessor is further configured to perform Manchester decoding as wellas error detection and correction upon the encoded data signals receivedfrom the transmitter unit 102.

In a further implementation, the one or more of the first unit 102, thebase unit 110, the second unit 105, and/or the infusion section 109 maybe configured to receive the blood glucose value wirelessly over acommunication link from, for example, a glucose meter. In still afurther implementation, the user or patient manipulating or using theanalyte monitoring system 100 (FIG. 3) may manually input the bloodglucose value using, for example, a user interface (for example, akeyboard, keypad, and the like) incorporated in the one or more of thefirst unit 102, the base unit 110, the second unit 105, or the infusionsection 109.

In the present description, the terms “component,” “module,” “device,”etc. may refer to any type of logical or functional process or blocksthat may be implemented in a variety of ways. For example, the functionsof various blocks can be combined with one another into any other numberof modules. Each module can be implemented as a software program storedon a tangible memory (e.g., random access memory, read only memory,CD-ROM memory, hard disk drive); to be read by a central processing unitto implement the functions of the innovations herein. Or, the modulescan comprise programming instructions transmitted to a general purposecomputer or to processing/graphics hardware via a transmission carrierwave. Also, the modules can be implemented as hardware logic circuitryimplementing the functions encompassed by the innovations herein.Finally; the modules can be implemented using special purposeinstructions (SIMD instructions), field programmable logic arrays or anymix thereof which provides the desired level performance and cost.

As disclosed herein, implementations and features of the invention maybe implemented through computer-hardware, software and/or firmware. Forexample, the systems and methods disclosed herein may be embodied invarious forms including, for example, a data processor, such as acomputer that also includes a database, digital electronic circuitry,firmware, software, or in combinations of them. Further, while some ofthe disclosed implementations describe components such as software,systems and methods consistent, with the innovations herein may beimplemented with any combination of hardware, software and/or firmware.Moreover, the above-noted features and other aspects and principles ofthe innovations herein may be implemented in various environments. Suchenvironments and related applications may be specially constructed forperforming the various processes and operations according to theinvention or they may include a general-purpose computer or computingplatform selectively activated or reconfigured by code to provide thenecessary functionality. The processes disclosed herein are notinherently related to any particular computer, network, architecture,environment, or other apparatus, and may be implemented by a suitablecombination of hardware, software, and/or firmware. For example, variousgeneral-purpose machines may be used with programs written in accordancewith teachings of the invention, or it may be more convenient toconstruct a specialized apparatus or system to perform the requiredmethods and techniques.

Aspects of the method and system described herein, such as the logic,may be implemented as functionality programmed into any of a variety ofcircuitry, including programmable logic devices (“PLDs”), such as fieldprogrammable gate arrays (“FPGAs”), programmable array logic (“PAL”)devices, electrically programmable logic and memory devices and standardcell-based devices, as well as application specific integrated circuits.Some other possibilities for implementing aspects include: memorydevices, microcontrollers with memory (such as EEPROM), embeddedmicroprocessors, firmware, software, etc. Furthermore, aspects may beembodied in microprocessors having software-based circuit emulation,discrete logic (sequential and combinatorial), custom devices, fuzzy(neural) logic, quantum devices, and hybrids of any of the above devicetypes. The underlying device technologies may be provided in a varietyof component types; e.g., metal-oxide semiconductor field-effecttransistor (“MOSFET”) technologies like complementary metal-oxidesemiconductor (“CMOS”), bipolar technologies like emitter-coupled logic(“ECU), polymer technologies (e.g., silicon-conjugated polymer andmetal-conjugated polymer-metal structures), mixed analog and digital,and so on.

It should also be noted that the various logic and/or functionsdisclosed herein may be enabled using any number of combinations ofhardware, firmware, and/or as data and/or instructions embodied invarious machine-readable or computer-readable media, in terms of theirbehavioral, register transfer, logic component, and/or othercharacteristics. Computer-readable media in which such formatted dataand/or instructions may be embodied include, but are not limited to,non-volatile storage media in various forms (e.g., optical, magnetic orsemiconductor storage media) and carrier waves that maybe used totransfer such formatted data and/or instructions through wireless,optical; or wired signaling media or any combination thereof. Examplesof transfers of such formatted data and/or instructions by carrier wavesincluded but are not limited to, transfers (uploads; downloads, e-mail,etc.) over the Internet and/or other computer networks via one or moredata transfer protocols (e.g., HTTP, FTP, SMTP, and so on).

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise,” “comprising,” and thelike are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense; that is to say, in a sense of “including,but not limited to.” Words using, the singular or plural number alsoinclude the plural or singular number respectively. Additionally, thewords “herein,” “hereunder,” “above,” “below,” and words of similarimport refer to this application as a whole and not to any particularportions of this application. When the word “or” is used in reference toa list of two or more items, that word covers all of the followinginterpretations of the word: any of the items in the list, all of theitems in the list and any combination of the items in the list.

Advantages of the system and method disclosed above include: 1) betterability to diagnose the cause of reduced radio performance; 2) betterguidance to the user to improve radio performance, and 3) reduced powerconsumption which will extend battery life.

The Navigator® controller, when used on a combined product (CGM insulinpump remote control) can implement the logic to realize the benefits.Any dual radio system could benefit. For example, a Bluetooth-enabledcell phone could combine the status of the Bluetooth connection andcellular network connection to give better guidance to the user toimprove the performance. Furthermore, different frequencies are notnecessary in another embodiment. The same frequency could be used withthe same protocol for different devices, but the wireless links would bedifferent by means of particular data identifier as belonging to aparticular link and device. An example of a two-link system that usesthe same frequency and protocol is a hospital system that monitors two(or more) glucose sensors on two (or more) patients with one controller.The protocol differentiates the two glucose sensor signals by device ID(identification number). The status of each link can indicate the statusof the system. For example, one patient is out of range while anotherpatient is in range.

Other implementations of the invention will be apparent to those skilledin the art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the disclosure above in combinationwith the following paragraphs describing the scope of one or moreimplementations of the following invention.

1-21. (canceled)
 22. A communication link analysis system for use with aplurality of medical devices in wireless communication with each other,the system comprising: a medical sensor device having a sensor devicewireless communication unit; a medical delivery device having a pumpdevice wireless communication unit; a display device configured tovisually display information to a user; a controller device having aprocessor, a first wireless communication unit, and a second wirelesscommunication unit, wherein the processor is programmed to establish afirst communication link between the first wireless communication unitand the sensor device wireless communication unit, and the processor isprogrammed to establish a second communication link between the secondwireless communication unit and the delivery device wirelesscommunication unit; wherein the processor is further programmed tomonitor each of the first and second communication links for status andfor the existence of degradation, and if degradation is detected in awireless communication link, the processor is further programmed tocompare the first wireless link status with the second wireless linkstatus to determine the cause of the detected degradation; and whereinthe processor is further programmed to control the display to visuallyprovide a user with guidance on how to resolve the degradation.
 23. Thecommunication link analysis system of claim 1, wherein: at least one ofthe sensor device and the delivery device comprises a latency in itswireless communications over its respective wireless communication link;and the processor is further programmed with the amount of the latencyand is further programmed to factor the latency into monitoring therespective communication link with that device and in comparing thestatus of the links.
 24. The communication link analysis system of claim23 wherein the processor is further programmed to factor latency intocomparing by extending its comparison of the status of the links beyondthe latency.
 25. The communication link analysis system of claim 22,wherein the processor is further programmed to establish the firstcommunication link with the sensor device before establishing the secondcommunication link with the delivery device.
 26. The communication linkanalysis system of claim 22, wherein the processor is further programmedto control the controller device to cease monitoring a link based on thecomparison, whereby power of the controller device is conserved.
 27. Thecommunication link analysis system of claim 22, wherein the sensordevice wireless communication unit is integrated into the sensor device.28. The communication link analysis system of claim 22, wherein thedelivery device wireless communication unit is integrated into thedelivery device.
 29. The communication link analysis system of claim 22,wherein the processor is programmed to determine signal strength of eachof the communication links and compare the signal strengths to oneanother when making the comparison of links.
 30. The communication linkanalysis system of claim 22, wherein the sensor device comprises atemperature sensor configured to provide temperature signals, whereinthose temperature signals are communicated to the controller over thecommunication link of the sensor device.
 31. The communication linkanalysis system of claim 22, wherein the sensor device comprises ananalyte sensor device and the delivery device comprises a pump.
 32. Thecommunication link analysis system of claim 22, wherein the processor isfurther programmed to monitor the communication links to identify anexistence of an intermittent communication link, and to consider theintermittent link in the comparison so that the intermittentcommunication will not be assigned the status of degradation.
 33. Thecommunication link analysis system of claim 22, wherein the processor isfurther programmed to control the controller device to cease monitoringa communication link based on the comparison, whereby power of thecontroller device is conserved.
 34. The communication link analysissystem of claim 22, wherein the processor is further programmed todetermine a status of at least one of the sensor device and pump devicebased on the communication links comparison.
 35. A method of analyzingcommunication links used by medical devices in wireless communicationwith each other, the method comprising: establishing a first wirelesscommunication link between a medical sensor device and a controllerdevice; establishing a second wireless communication link between amedical delivery device and the controller device; monitoring each ofthe first and second communication links for status and for theexistence of degradation; if degradation is detected in a wirelesscommunication link, comparing the first wireless link status with thesecond wireless link status to determine the cause of the detecteddegradation; and visually displaying guidance to a user on how toresolve the degradation.
 36. The method of analyzing communication linksof claim 35: wherein at least one of the first and second wirelesscommunication links comprises a latency in the device communicating overthe link; and the method further comprising factoring the latency intothe steps of monitoring the respective communication link and comparingthe status of the links.
 37. The method of analyzing communication linksof claim 36 wherein the step of comparing communication links, one ofwhich has a latency, comprises extending the comparison of the status ofthe links beyond the latency.
 38. The method of analyzing communicationlinks of claim 35, wherein the step of establishing a first wirelesscommunication link between a medical sensor device and a controllerdevice is performed prior to the step of establishing a second wirelesscommunication link between a medical delivery device and the controllerdevice.
 39. The method of analyzing communication links of claim 35,further comprising ceasing the monitoring of a link based on thecomparing step, thereby conserving power of the controller device. 40.The method of analyzing communication links of claim 35, wherein thestep of comparing the links further comprises comparing signal strengthsof the links.
 41. The method of analyzing communication links of claim35, further comprising the step of: sensing temperature at the sensordevice and providing sensed temperature signals; and communicating thesensed temperature signals over the first communication link to thecontroller.
 42. The method of analyzing communication links of claim 35,further comprising the steps of: monitoring the communication links toidentify the existence of an intermittent communication link; andconsidering the intermittent communication link in the comparing step sothat the intermittent communication will not be assigned the status ofdegradation.
 43. The method of analyzing communication links of claim35, further comprising the step of controlling the controller device tocease monitoring a link based on the comparing step, whereby power ofthe controller device is conserved.
 44. The method of analyzingcommunication links of claim 35, further comprising the step ofdetermining a status of at least one of the sensor device and deliverydevice based on the comparing step.